QC Manager in Analytics in Basel 100%
Background:
As a QC Manager in Analytics, you will be part of the Quality Control ASAT Support team.
The position is open due to workload increase (product launch).
Role:
* Will be responsible for writing transfer and validation plans for Small & Large Molecules analytical methods
* Writing of SOP's and analysis instructions
* Technical support and reports writing of the QC routine laboratory for trouble shooting (e.g. HPLC)
* Management of Standard Deviations
* Processing inquiries about products
* Support of the Track & Trend project in the release and stability analysis
* Participation in international product meetings and conference calls in English
Requirements:
* Minimum 5 years' experience in Quality Control
* Extensive experience of analytical validation & protocols writing
* Experience in HPLC and chemo-physical analysis techniques
* Experience industry (global matrix environment needed - 7-8 years)
* Working knowledge of TrackWise system
* BSc/MSc/PhD in Chemistry (Chemical Engineering) or equivalent (Biology, biotechnology)
* Knowledge of the ICH or FDA guidelines for Small Molecules Drug Products and analytical validations, as well as knowledge of the compendial pharmacopoeia methods for Small Molecules Drug Products
* GMP experience
* Team player with an open-minded personality
* Very good German and English (German = office language ; English = documentation to be written in English)
Nice to have:
* Good knowledge of statistical applications in Excel, Minitab, JMP or similar statistics software and overall interest in statistics.
Reference: 919041
Industry: Pharma
Location: Region Basel
Start: ASAP
Duration: 12 Months +
Work Load: 100%
About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.
Contact me for further information regarding our company, our positions or our attractive payroll-only-program: +41 41 555 53 03.
Apply now